Phase 2
Completed N=120
Blood Pressure After Endovascular Stroke Therapy-II
Stroke · Endovascular Thrombectomy
Source: ClinicalTrials.gov NCT04116112 ↗
Enrolled (actual)
120
Serious AEs
6.7%
Results posted
Oct 2023
Primary outcomePrimary: Final Infarct Volume — 46.4; 50.7; 32.4 Cubic Centimeters
Summary
The purpose of this study is to assess the safety of lowering blood pressure in acute stroke patients that are successfully treated with a mechanical thrombectomy procedure. The investogators will evaluate the hypothesis that lower blood pressure management strategies do not result in larger volume of stroke or worse 3-month clinical outcome in these patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Final Infarct Volume |
46.4; 50.7; 32.4 | — |
| PRIMARY Utility-weighted Modified Rankin Score |
0.58; 0.47; 0.51 | — |
| SECONDARY Number of Participants With Any Hemorrhagic Transformation |
12; 12; 14 | — |
| SECONDARY Number of Participants With Symptomatic Hemorrhagic Transformation |
2; 1; 2 | — |
| SECONDARY Number of Participants With Neurological Worsening Associated With Antihypertensive Treatment |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients (≥18 years)
- Undergoing successful EVT (defined as modified Thrombolysis in Cerebral Ischemia Score, mTICI, ≥2b) for an occlusion in the anterior cerebral circulation large vessel (internal carotid artery and M1 or M2 segments of the middle cerebral artery).
- Intervention will be initiated only for those with a successful recanalization (modified Thrombolysis in Cerebral Ischemia Score ≥ 2b).
- Undergoing a baseline CT or MR perfusion study
- Those with unsuccessful recanalization (mTICI 0-2a) will be not intervened upon.
Exclusion Criteria
- Known heart failure with ejection fraction <30%
- Presence of a left ventricular assist device
- Patients undergoing extracorporeal membrane oxygenation
- Pregnancy
- Enrollment in any other clinical trial
Data sourced from ClinicalTrials.gov (NCT04116112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.